Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

Ankle Osteoarthritis Clinical Trial

Official title:

Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356951
• Other study ID #: MAT
• Status: Completed
• Phase: N/A
• First received: November 19, 2017
• Last updated: December 1, 2017
• Start date: March 16, 2017
• Est. completion date: June 29, 2017

Study information

• Verified date: November 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.

Description:

Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee

• Males or females aged between 20 and 80 years old.

• Patients with diagnosis of primary not-inflammatory degenerative articular disease

Exclusion Criteria:

• Patients with Body Mass Index (BMI)> 35.

• Patients with active or suspected latent periprosthetic infection

• Patients who underwent revision surgery.

• Prosthesis of the hip, knee or ankle, homolateral or contralateral.

• Fusion failure of subtalar joint.

• Patients with chronic heart failure (NYHA stage> 2)

• Presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies

• Cognitive deficits.

• Impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

Procedure:
• TAR through anterior approach and subtalar fusion
Simultaneous total ankle replacement through anterior approach and subtalar fusion
• TAR through lateral approach and subtalar fusion
Simultaneous total ankle replacement through lateral approach and subtalar fusion

Locations

Country	Name	City	State
Italy	IRCCS Galeazzi Orthopedic Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait analysis	Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs	1 day
Secondary	VAS (Visual Analog Scale)	Differences in Pain Scores on the Visual Analog Scale	1 day
Secondary	AOFAS	Differences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score	1 day
Secondary	Short Form Health Survey (SF-12)	Differences in Health Scores on the 12-Item Short Form Health Survey	1 day